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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

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AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1012623-29
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 03/10/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Date of implant has been estimated.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that on approximately(b)(6) 2017 a 7.0 x 29 mm omnilink stent was implanted in the left leg of the patient.Although the procedure was successfully completed with no clinically significant delay and no adverse patient effects, the patient reported on (b)(6) 2018 that both his legs started to feel itchy a few days ago and is currently taking medication.No additional information was provided.
 
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Brand Name
OMNILINK ELITE PERIPHERAL STENT SYSTEM
Type of Device
PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7370288
MDR Text Key103462498
Report Number2024168-2018-02172
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08717648179259
UDI-Public08717648179259
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Other
Type of Report Initial
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue Number1012623-29
Device Lot Number7040641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/13/2018
Initial Date FDA Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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